TECNIS IOL
Report
- Report Number
- 3012236936-2025-000313
- Event Type
- Injury
- Date Received
- November 25, 2025
- Report Date
- March 12, 2026
- Manufacturer
- AMO PUERTO RICO MFG. INC.
- Product Code
- MJP
- UDI-DI
- 05050474746527
- PMA / PMN Number
- P980040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: JAN 12, 2026. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE LENS WAS CUT IN HALF. NO ISSUE THAT COULD CONTRIBUTE TO THE COMPLAINT EVENTS REPORTED WERE OBSERVED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DIU150 MODEL LENS. THE ¿LENS CUT¿ OBSERVED DURING PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.
CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT AN INCORRECT CODE OF "2138" WAS INADVERTENTLY ENTERED IN SECTION "H6 -HEALTH EFFECT - CLINICAL CODE" OF THE INITIAL MDR REPORT INSTEAD OF CODE "2271" WHICH SHOULD HAVE BEEN ENTERED IN THE SECTION "H6- HEALTH EFFECT - IMPACT CODE". THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AS INDICATED BELOW: THE FOLLOWING CODE WAS ADDED: SECTION H6 -HEALTH EFFECT - IMPACT CODE: 2271 - THERAPEUTIC RESPONSE DECREASED. THE FOLLOWING CODE IS NO LONGER APPLICABLE: SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 2138 - VISUAL IMPAIRMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
CORRECTED DATA: UPON REVIEW, IT WAS NOTED THAT THE ¿ADDITIONAL INFORMATION¿ AND ¿DEVICE EVALUATION¿ BOXES WERE INADVERTENTLY LEFT UNCHECKED AND BLANK IN SECTIONS H2 AND H3 OF FOLLOW-UP MDR REPORT #2. THESE OMISSIONS HAVE BEEN CORRECTED IN THIS SUPPLEMENTAL MDR, AND THE CORRESPONDING FIELDS HAVE NOW BEEN UPDATED ACCORDINGLY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.
SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN AUG 25, 2025 AND OCT 21, 2025. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A REFRACTIVE CHANGE WAS NEEDED FOR THE PATIENT. THE PATIENT WANTED DISTANCE AND TORIC ROTATION AND REPORTED LOSS OF DEPTH PERCEPTION THAT INTERFERED WITH DAILY ACTIVITIES. THE IOL WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY PROCEDURE. NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE PATIENT DID NOT SEEK FURTHER MEDICAL ATTENTION AND DID NOT RECEIVE ANY MEDICATION OUTSIDE THE STANDARD OF CARE. THE DIRECTIONS FOR USE WERE FOLLOWED. THE REPORTED OUTCOME WAS TEMPORARY IMPAIRMENT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1948154 | TECNIS IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | AMO PUERTO RICO MFG. INC. | DIU150 | 05050474746527 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention |